Last week, everything at pro aqua revolved around quality assurance: We successfully completed our internal audit for the EN ISO 13485 and EN ISO 9001 standards. We have proudly held both certificates since 2024. However, an integrated Quality Management System (QMS) is not a rigid paper construct – it thrives on being continuously developed and improved.
Our QM Manager, Tatjana Schweiger , comprehensively reviewed the entire system.
From responsibilities and our corporate values to document control and clearly defined process workflows: No area was left unexamined.
A System that Moves – and Connects
Behind this success lies a massive team effort. At pro aqua, our everyday processes were not radically changed; instead, they were anchored within the Quality Management System and, where necessary, adapted or expanded to comply with the standards.
This was only possible thanks to the active participation of the entire team. Everyone is pulling in the same direction and filling the system with real life. The result is a Quality Management System that both meets all requirements and meaningfully supports our daily work.
Following the audit, Tatjana Schweiger drew an extremely positive conclusion:
"Implementing a Quality Management System according to EN ISO 9001, and especially meeting the requirements of the Medical Device Regulation, demands a lot from everyone. This makes me all the prouder to see how wonderfully the team is shaping this system. Quality management is now deeply embedded in our routines. Everyone is proactively contributing, bringing in their own ideas, and actively driving our Continuous Improvement Process (CIP) forward."
Sustainable Quality for the Highest Demands
The audit result proves it in black and white: The effort has more than paid off. Through this active QMS, we consistently meet the strict criteria for medical device manufacturing (EN ISO 13485) as well as the general quality standards of EN ISO 9001.
A huge thank you goes to Tatjana for her fantastic guidance through the audit, and to the entire team for their tireless commitment to making pro aqua a little better every single day!
A History of Proven Excellence
This successful internal audit seamlessly builds upon our previous milestones. During the official ISO surveillance audit conducted by PMG (European Inspection and Certification Body for Medical Devices), pro aqua was already certified to have workflows that serve as a prime example for a modern, process-oriented organization.
For us, quality is never a coincidence; it is deeply embedded in our corporate DNA. Whether it is preventing errors through clear work instructions, precisely meeting the expectations of our clientele, or balancing environmental responsibility with innovation through our CIP (Continuous Improvement Process): We never chase the status quo, but always strive for the next level of safety and perfection.
Would you like to read more about how we set the highest quality standards? You can find the detailed report on our official surveillance audit here: Excellent Quality Confirmed: pro aqua Successfully Completes ISO Surveillance Audit.